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Fresenius Kabi

Global provider of therapies and devices

Principal Cybersecurity Engineer

Security Engineering & ArchitectureConfirmed live in the last 24 hours
Full-timeIn-person

About the Job

Requirements

  • A Bachelor's degree in Computer Science, Computer Engineering, Cybersecurity, or related Engineering is required.
  • At least 8 years of experience in cybersecurity, software engineering, product security, or a related technical discipline, including applying cybersecurity practices to software-based products.
  • Demonstrated experience applying FDA cybersecurity guidance, IEC 81001-5-1, IEC 62304, ISO 14971, and related cybersecurity standards within regulated medical device development environments.
  • Experience conducting cybersecurity risk assessments and supporting risk management activities in accordance with ISO 14971.
  • Experience with vulnerability assessment and management, software bill of materials governance, security analysis, and threat modeling is required.
  • Experience applying cybersecurity principles to embedded medical device software and/or web applications.
  • Remain current with the evolving cybersecurity landscape and its applicability to medical devices.
  • Experience applying cybersecurity principles to on-premises and cloud-based systems, including web applications, application programming interfaces, containerized workloads, and hybrid architectures.
  • Experience planning and executing cybersecurity penetration testing activities.
  • Experience with Static Application Security Testing (SAST), Dynamic Application Security Testing (DAST), and Software Composition Analysis (SCA).
  • Ability to work collaboratively as a team member.
  • Advanced problem-solving, analytical, troubleshooting, and debugging skills.
  • Strong attention to detail and a methodical approach.
  • Excellent written and verbal communication skills.
  • Must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English.

Responsibilities

  • Guide the conceptualization of new secure methodologies and identify improvements to processes and best practices in product cybersecurity for all aspects of the IMS and LVP products.
  • Develop and implement cybersecure solutions to complex problems using multiple disciplines and technical principles.
  • Analyze, plan, design, execute, and document the security of highly complex software applications and/or processes within established medical product design controls.
  • Plan and perform security testing through manual and automated means for new features, enhancements, and defect fixes across multiple software subsystems.
  • Lead secure design reviews, security requirements definition, and security architecture reviews, providing technical direction for authentication, authorization, encryption, secure communications, key management, cloud security, and secure software design patterns.
  • Participate in operational cybersecurity activities, including Coordinated Vulnerability Disclosure (CVD), Product Security Incident Response Team (PSIRT) processes, vulnerability investigations, and post-market cybersecurity activities.
  • Develop and maintain product threat models using methodologies such as STRIDE, attack trees, abuse cases, and adversarial analysis techniques.
  • Develop, review, and maintain cybersecurity standard operating procedures and recommend continuous process improvements to maintain compliance with global regulatory standards and agency regulations. Conduct ongoing vulnerability scanning and risk evaluations.
  • Support and advance Secure Software Development Lifecycle (Secure SDLC) practices across product development teams.
  • Drive implementation of DevSecOps practices, including automated security testing, policy enforcement, software bill of materials generation, vulnerability management, and secure continuous integration/continuous delivery (CI/CD) pipelines.
  • Provide guidance on secure coding practices and remediation of cybersecurity vulnerabilities throughout the software development lifecycle.
  • Work with senior leadership to improve cybersecurity engineering process efficiency. Work with global internal and external staff to identify cybersecurity coverage needs and high-risk areas, and improve overall software cybersecurity and robustness.
  • Mentor and guide junior staff, routinely provide technical input on architecture and design decisions to improve cybersecurity, and remain a hands-on individual contributor within the development team. May supervise or direct lower-level engineers on assigned projects.
  • Develop and maintain technical records and detailed documentation for internal and external stakeholders, following standard practices and good documentation procedures.

Desired Qualifications

  • Experience supporting FDA submissions and regulatory audits is highly desired.

About the Company

Fresenius Kabi

Global provider of therapies and devices

Fresenius Kabi is a global healthcare company that provides medicines, medical devices, and services for the treatment of critically and chronically ill patients. Its portfolio includes biosimilars for autoimmune diseases and cancer, clinical nutrition products, infusion pumps and related disposables, blood collection bags and devices, and IV generics and fluids. It stands out with leading market positions in areas like blood collection and infusion materials and offers an integrated mix of pharma, nutrition, and MedTech offerings under the FutureFresenius strategy. Its goal is to shape the future of healthcare by expanding its global therapies and technologies, improving patient care, and delivering sustainable value for stakeholders.

Company size
10,001+
Company stage
Not listed
Total funding
Not listed
Headquarters
Bad Homburg, Germany
Founded
1999

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